Impact of Perivascular Tissue on Endothelial Function in Coronary Artery Bypass Grafting

Norwegian University of Science and Technology100 enrolled

Overview

The success of coronary artery bypass grafting is reliant on the quality of the grafts used. A new technique for harvesting veins used as grafts has been introduced. The study hypothesis is that veins harvested with this technique have an improved endothelial function.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

100

Conditions

Myocardial Ischemia

Interventions

no-touchPROCEDURE

The saphenous vein is exposed by a longitudinal incision, and all visible side branches ligated. The vein is then isolated together with a pedicle of surrounding tissue and manually distended and stored in a combination of blood and saline using a syringe, according to standard procedure at St. Olav's Hospital.

conventionalPROCEDURE

The saphenous vein is exposed by a longitudinal leg incision, skeletonized from surrounding tissue, and side branches ligated. The vein is removed from the leg immediately after dissection, manually distended and stored in a combination of blood and saline using a syringe, according to standard procedure at St. Olav's Hospital.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Isolated elective, primary CABG requiring cardiopulmonary bypass * Left ventricular ejection fraction \>35% * at least one saphenous vein graft required as part of revascularization strategy Exclusion Criteria: * Acute or chronic inflammatory diseases * Malignancies * Pregnancy * Previous cardiac surgery * Serum creatinine \>120 μmol/L * Coagulopathy * Insulin dependent diabetes mellitus * Smoking during last 6 months * Leg not suitable for No-touch vein harvesting as judged by the operator. * Need for nitrates on operation day * not receiving statins

Locations (1)

Institute for Circulation and Imaging

Trondheim, Sør-Trøndelag, Norway

Outcomes

Primary Outcomes

Graft function

Graft function as evaluated by coronary angiography in the first 60 out of 100 patients

Time frame: 6 months

Graft function

Graft function as evaluated by coronary angiography in all 100 patients

Time frame: 5 years

Secondary Outcomes

Morphological appearance of vein graft

As measured by angiography follow-up in the first 60 out of 100 patients

Time frame: 6 months

Morphological appearance of vein graft

As measured by angiography follow-up in all 100 patients

Time frame: 5 years

Postoperative leg wound complications

The following measures will be assessed in the first 60 out of 100 patients: * Signs of infection * Wound dehiscence * Aesthetics * Cutaneous sensory loss * Wound discomfort

Time frame: 6 weeks

Postoperative complications related to cardiac surgery

Major adverse cardiac and cerebral events in the first 60 out of 100 patients * Postoperative complications * Reoperation * Sternal dehiscence * Mediastinitis

Time frame: Discharge, 6 weeks, 6 months

Postoperative complications related to cardiac surgery

Major adverse cardiac and cerebral events in all 100 patients * Postoperative complications * Reoperation * Sternal dehiscence * Mediastinitis

Time frame: 5 years

Data from ClinicalTrials.gov

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